FDA Adverse Event Malfunction Summary report: N

SPES MEDICA SUBDERMAL NEEDLE ELECTRODES

MDR report key: 23804476 · Received December 15, 2025

Report

Report Number
23804476
Event Type
Malfunction
Date Received
December 15, 2025
Date of Event
June 15, 2025
Report Date
October 6, 2025
Manufacturer
SPES MEDICA SPA
Product Code
GXZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
BIOMEDICAL ENGINEER
Health Professional
Yes

Narratives

Description of Event or Problem · 0

AT CLOSING OF THE SURGERY, THE NEURO-MONITORING TECHNICIAN PROCEEDED TO REMOVE THE NEURO-MONITORING NEEDLES. ONE STRAIGHT NEEDLE WAS MISSING APPROXIMATELY 1CM OF THE NEEDLE AT THE RIGHT ANTERIOR FEMORAL / GROIN AREA. THE TECHNICIAN CAREFULLY EXAMINED THE ELECTRODES AT THE TIME OF REMOVAL AND NOTICED THAT THE NEEDLE BROKE FROM THE HUB, MOST LIKELY WHERE THE NEEDLE WAS SOLDERED TO THE NEEDLE ELECTRODE WIRE. AN X-RAY REVEALED THAT THE NEEDLE WAS LOCATED IN THE RIGHT GROIN AREA. THE ATTENDING SURGEON SPOKE WITH THE PATIENT'S FAMILY FOR SUGGESTED REMOVAL OF THE RETAINED PIECE OF NEEDLE. HOWEVER, THE PATIENT'S FAMILY REFUSED THE SUGGESTED REMOVAL. NO PATIENT HARM WAS NOTED AT THIS TIME. MANUFACTURER RESPONSE FOR NEURO-MONITORING SUBDERMAL NEEDLE ELECTRODE, TWISTED SUBDERMAL NEEDLE ELECTRODE (PER SITE REPORTER). SPES MEDICA CAME TO FACILITY TO WORK WITH NEURO-MONITORING. SPES MEDICA DID A THOROUGH PRODUCT REVIEW. THEY DID NOT FIND ANOTHER OCCURRENCE FOR THE PRODUCT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
766423 SPES MEDICA SUBDERMAL NEEDLE ELECTRODES ELECTRODE, NEEDLE GXZ SPES MEDICA SPA MN4013D15A/S

Patients

Seq Age Sex Outcome Treatment
1 17 YR Female Other